SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit 에 대한 현장 안전성 서한
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Getinge 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
데이터 추가 비고
원인
During internal pressure (leak) testing of the sensation plus 8fr. 50cc, iabc, failures related
to the tip seal leak were identified within the lot number listed above. this issue at the catheter tip
seal could potentially cause a leak in the balloon and may lead to an interruption of therapy
resulting in the need to replace the defective iabc with a new catheter. such occurrences could
cause momentary hemodynamic instability in the patient, or potential complications related to
vessel bleeding related to replacement of the iab catheter. to date, there have been no reports of
serious injury. .